FDA Medical devices recall ·
Microscissor Tip (Disposable) recall
- Recall number
- Z-0663-2025
- Date
- (initiated November 5, 2024)
- Company / brand
- Microline Surgical, Inc.
50 Dunham Rd Ste 1500, Beverly, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 200 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Why was it recalled?
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.
Distribution
Worldwide - US Nationwide in the state of OK and the country of Japan.
States: Oklahoma
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0663-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.